The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Guedel Airway.
| Device ID | K953400 |
| 510k Number | K953400 |
| Device Name: | GUEDEL AIRWAY |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Robert A Virag |
| Correspondent | Robert A Virag MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1995-10-24 |